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Last month, Novartis disclosed that it received a warning letter from the Food and Drug Administration about manufacturing issues at two facilities in India that are operated by its Sandoz generic drug unit…At the time, the company noted it was working closely with the FDA to resolve the problems. But Novartis never actually specified what bothered the agency. Now, the warning letter has been posted on the FDA website, and the infractions are concerning, especially given that the plants are run by one of the world’s largest suppliers of generic medicines…The disclosure comes amid ongoing FDA scrutiny of overseas manufacturing plants, particularly in India, where a string of drug makers has failed inspections and had products banned from the US. The Indian pharmaceutical industry is furious that the agency appears to be singling out its ranks for infractions; however the Sandoz letter indicates the FDA is not confining its reviews to India’s domestic drug makers…A key issue that alarmed the agency during its August 2014 inspections was the integrity of the data Sandoz was collecting…“Backdating … records is unacceptable,” the FDA wrote in its Oct. 22 warning letter. The agency also expressed concern that Sandoz failed to demonstrate the extent to which such practices may be widespread and — this is significant — whether previous data is even reliable.

Hundreds of genetically modified mosquitoes that are incapable of spreading the malaria parasite to humans have been created in a laboratory as part of a radical approach to combating the disease…The move marks a major step towards the development of a powerful and controversial technology called a “gene drive” that aims to tackle the disease by forcing anti-malarial genes into swarms of wild mosquitoes…mosquitoes were engineered to carry genes for antibodies that target the human malaria parasite...When released into the wild, researchers believe the modified insects will breed with normal mosquitoes and pass the anti-malarial genes on to their young, making an ever-increasing proportion of future generations resistant to the malaria parasite…To track which insects inherited the antibody genes, the scientists added a tracer gene that gave carriers red fluorescent eyes…Concern that drug and insecticide resistance are eroding recent successes in managing malaria has drawn attention to alternative approaches, including the use of genetically modified mosquitoes.

..FBI…announced a $390 million settlement against NOVARTIS...in a civil fraud lawsuit based on claims that NOVARTIS gave kickbacks to specialty pharmacies in return for recommending two of its drugs, Exjade (deferasirox) and Myfortic (mycophenolic acid)…two specialty pharmacies, Bioscrip, Inc. and Accredo Health Group, agreed to pay a total of $75 million to resolve federal and state claims against them based on the same allegations...today’s settlement, the federal and state governments will recover $465 million in total based on the kickback allegations in this lawsuit…a whistleblower, and asserted that NOVARTIS violated the False Claims Act and the Anti-Kickback Statute…by giving kickbacks to specialty pharmacies in return for recommending Exjade…and Myfortic…With respect to Exjade, the Government alleged that NOVARTIS gave kickbacks in the form of patient referrals and rebates to Bioscrip and Accredo to induce those pharmacies to recommend Exjade refills…the Government alleged that, to increase Exjade sales, Novartis incentivized and pressured the pharmacies to emphasize Exjade’s benefits to patients while understating the drug’s serious, potentially life-threatening, side effects. With respect to Myfortic, the Government alleged that NOVARTIS gave rebate contracts to specialty pharmacies to induce the pharmacies to recommend to doctors that they switch patients to Myfortic from competitor drugs.

Which health care companies have traditionally been the most shareholder friendly? Turns out Pfizer…is one of them. But what about the rest of the sector?...Health care companies have been actively returning capital to shareholders over the past 10 years, but not all of its sub-industries were active participants. However, that may change, particularly as several biotech companies start to mature…"Biotech has been increasingly active in repurchasing shares during the past five years,"…."We expect these trends to continue in the next several years, and we anticipate that more biotech companies will engage in similar capital deployment activities in the future as their businesses mature and they begin generating steady cash flows. Although we do not anticipate biotech to overtake the pharmaceutical industry."…So which health care companies have led the way with the most returned capital to shareholders over the past 10 years? Here's the list..

1. Pfizer Inc.; Pharmaceuticals; YTD return: 3.3%; TRC 2005-2014: $127.37 billion
2. Johnson & Johnson; Pharmaceuticals; YTD return: -2%; TRC 2005-2014: $108.4 billion
3. Merck & Co. Inc.; Pharmaceuticals; YTD return: -4.7%; TRC 2005-2014: $68.1 billion
4. Amgen Inc.; Biotech; YTD return: 0.39%; TRC 2005-2014: $39.56 billion
5. United Health Group Inc.; Managed Health Care; YTD return: 11.7%; TRC 2005-2014: $36.27 billion
6. HCA Holdings Inc.; Health Care Facilities; YTD return: -8.1%; TRC 2005-2014: $33.54 billion
7. Abbott Laboratories; Health Care Equip ; YTD return: 2.2%; TRC 2005-2014: $33.16 billion
8. Anthem Inc.; Managed Health Care; YTD return: 4.5%; TRC 2005-2014: $33.11 billion
9. Bristol-Myers Squibb Co.; Pharmaceuticals; YTD return: 14.9%; TRC 2005-2014: $27.6 billion
10. Medtronic Plc ; Health Care Equip ; YTD return: 4.7%; TRC 2005-2014: $24.4 billion

Take that, Theranos!..Clearly determined to offer direct-to-consumer lab testing through pharmacies, grocery chain Safeway seems to be shaking off the reported demise of a partnership with the not-so-revolutionary-after-all testing company (Theranos)… Sonora Quest Laboratories, a joint venture of Quest Diagnostics and Phoenix’s Banner Health, has opened its first testing center at a Safeway in...Scottsdale, Arizona. A second one will open next week in an upscale part of Phoenix...

Treating hepatitis C with expensive new medicines at the earliest signs of liver damage improves patients' health and is also cost-effective, a new computer simulation suggests…"Going into this, I expected to find it did make sense to wait until there was a limited amount of liver disease, but what we found to our surprise is that it makes sense to start treatment at the earliest change in the liver,"…researchers created a simulated model to study the cost-effectiveness of a medicine…The imaginary subjects…of varying ages and with various stages of liver damage… While treating all stages of liver disease was cost-effective, the up-front cost is substantial. Treating half of those with hepatitis C would cost about $53 billion. That cost can be brought down if the price of the drug also decreases, the researchers write…"I think a key policy point here is that cost-effectiveness is important and this study shows that, but a next and important step is...to address the cost of the drug,"

The Compounding Expert Committee approved a new General Chapter, <800> Hazardous Drugs—Handling in Healthcare Settings. The purpose of this General Chapter is to provide standards to protect personnel, patients and the environment when handling hazardous drugs (HDs). The chapter applies to all healthcare personnel and all entities which handle HDs. Building on existing standards and guidelines, General Chapter <800> provides a comprehensive approach for handling HDs in healthcare settings with the ultimate goal of preventing and/or limiting potential exposures to HDs...The revised General Chapter <800> will be published on February 1, 2016 in the First Supplement to USP 39–NF 34. Additionally, the Expert Committee approved a delayed official implementation date of July 1, 2018 to allow entities more than two years to implement the chapter.

California and Oregon…will soon make access to birth control easier for millions of women by allowing them to obtain contraceptives from pharmacists without a doctor’s prescription…Most Western countries require a doctor’s prescription for hormonal contraceptives…but starting sometime in the next few months, women in California and Oregon will be able to obtain these types of birth control by getting a prescription directly from the pharmacist who dispenses them, a more convenient and potentially less expensive option than going to the doctor…Pharmacists will be authorized to prescribe contraceptives after a quick screening process in which women fill out a questionnaire about their health and medical histories…pharmacists’ organizations, plan to lobby for it across the country…One unanswered question, however, is whether insurers will pay for the time pharmacists spend reviewing women’s questionnaires or helping evaluate options. To cover that cost, some pharmacists may charge fees...The laws in Oregon and California differ in some ways. California’s has no age restriction; the Oregon law requires that teenagers under 18 obtain their first contraceptive prescription from a doctor. In California, pharmacists will also most likely have to take women’s blood pressure for contraceptives containing estrogen.

All clinicians should prescribe generic medications whenever possible as a way to improve adherence to therapy and clinical outcomes while containing costs, “While the use of generic drugs has increased over time, clinicians often prescribe more expensive brand name drugs when equally effective, well proven, and less expensive generic versions are available,”…“The use of generic drugs is a High Value Care way to improve health, avoid harms, and eliminate wasteful practices.”… “ACP (American College of Physicians) recognizes that there are situations where generic substitution is not possible and the use of brand name drugs is clinically appropriate,”…Some of the underuse of generic medications is likely the result of patient and physician perceptions about the safety and a perceived lack of efficacy of the lower cost options. Patients may also associate the lower price of generics with lower levels of effectiveness… Public awareness and advertising campaigns similar to those used for brand name drugs might help to alter patient perceptions about generics…

Hyderabad-based drug maker Dr Reddy's has filed a lawsuit in a US court against Anglo-Swedish drug giant AstraZeneca alleging material breach of a settlement agreement that had released the company from any liability in connection with generic versions of Nexium (esomeprazole)…Last week, AstraZeneca as part of a lawsuit against Dr Reddy's moved in a Delaware Court obtained a temporary restraining order preventing the Indian firm from selling copies of Nexium on grounds of trademark infringement for using the colour purple, which was similar to the original brand.